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A phase II clinical trial of weekly paclitaxel and carboplatin in combination with panitumumab in metastatic triple negative breast cancer

机译:每周紫杉醇和卡铂联合帕尼单抗治疗转移性三阴性乳腺癌的II期临床试验

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Purpose: Women with metastatic triple negative breast cancer (TNBC) can have a poor prognosis with treatment limited to cytotoxic chemotherapy. The identification of effective therapies that may limit exposure to cytotoxic chemotherapy and lead to prolonged survival is an unmet medical need. We tested an inhibitor of the epidermal growth factor receptor, panitumumab in combination with chemotherapy. Methods: We conducted a single arm clinical trial in women with metastatic or locally advanced TNBC to paclitaxel 80mg/m2 and carboplatin AUC of 2 on days 1, 8, and 15 and panitumumab 6mg/kg on days 1 and 15 for a cycle length of 28days. The objectives were to evaluate the response rate and safety of the combination in comparison to historical controls. Results: Fourteen patients with TNBC were enrolled with a median age of 53years. The majority of women were African American (64.3%) with visceral metastasis (64.2%). Hematologic toxicities, particularly neutropenia and thrombocytopenia, were a major cause of missed chemotherapy and delayed treatment in this study. The overall response rate (complete and partial response) of the 13 evaluable patients was 46%. The median time to best response was 2.4 months and the median time to disease progression was 3.6 months. We were able to perform the PAM50 analysis on tumors from 7 of our subjects. All the samples tested clustered within the basal-like subtype. Conclusions: In our experience the response rate of carboplatin, paclitaxel and panitumumab was consistent with other reports of response for cytotoxic chemotherapy in metastatic TNBC.
机译:目的:患有转移性三阴性乳腺癌(TNBC)的妇女预后较差,只能进行细胞毒性化学治疗。尚未发现能够限制暴露于细胞毒性化学疗法并导致生存期延长的有效疗法。我们结合化学疗法测试了一种表皮生长因子受体抑制剂panitumumab。方法:我们对患有转移性或局部晚期TNBC的妇女进行了单臂临床试验,在第1、8和15天紫杉醇80mg / m2,卡铂AUC为2,在第1和15天使用panitumumab 6mg / kg,周期为28天。目的是评估与历史对照相比,组合的响应率和安全性。结果:14名TNBC患者入组,中位年龄为53岁。大部分女性为非裔美国人(64.3%),发生内脏转移(64.2%)。血液毒性,特别是中性粒细胞减少症和血小板减少症,是化疗失败和治疗延误的主要原因。 13名可评估患者的总缓解率(完全缓解和部分缓解)为46%。获得最佳反应的中位时间为2.4个月,达到疾病进展的中位时间为3.6个月。我们能够对7位受试者的肿瘤进行PAM50分析。所有测试样品均聚集在基底样亚型内。结论:根据我们的经验,卡铂,紫杉醇和帕尼单抗的反应率与转移性TNBC细胞毒性化疗反应的其他报道一致。

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